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Collect Breast Cancer Patients' Digital Mammography Images With Corresponding Reports for the Development of Software

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ClinicalTrials.gov Identifier: NCT00749255
Recruitment Status : Terminated (not enough personnel to conduct study at site)
First Posted : September 9, 2008
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving software design.

Condition or disease
Breast Cancer

Detailed Description:
The information is necessary for Sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself. The information will be used to develop algorithms that will foster development of CAD software. The information in each image and/or accompanying written clinical case documentation will not be analyzed in any way for clinical events

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: R2 Case Collection
Study Start Date : May 2008
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
FFDM
a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications)


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Known breast cancer patients
Criteria

Inclusion Criteria:

  • subjects with known breast cancer ages 18 and over
  • case images originating from Women's imaging or one of the affiliated screening centers. Raw images must be available for each image
  • source documents or mammographic interpretation must be available

Exclusion Criteria:

  • 17 or younger
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749255


Locations
United States, Pennsylvania
Women's Imaging @ WellSpan Health
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
WellSpan Health
Investigators
Principal Investigator: Misty Hicks, RTRM Women's Imaging @ WellSpan Health
More Information

Responsible Party: Misty Hicks, RTRM, Women's Imaging
ClinicalTrials.gov Identifier: NCT00749255     History of Changes
Other Study ID Numbers: 0708052
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011

Keywords provided by WellSpan Health:
Breast Cancer
Digital archiver software

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases